The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score \[NCCT ASPECTS\] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Utility-weighted 90-day Modified Rankin Score
Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. 1. = No significant disability despite symptoms; able to carry out all usual duties and activities. 2. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3. = Moderate disability requiring some help, but able to walk without assistance. 4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. = Death
Time frame: 90 days post randomization
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Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
Los Angeles, California, United States
Pomona Valley Hospital Medical Center
Pomona, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
California Pacific Medical Center & Mills Peninsula Medical Center
San Francisco, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Providence Saint John's Health Center
Torrance, California, United States
Boca Raton Regional Hospital Inc.
Boca Raton, Florida, United States
University of Miami
Coral Gables, Florida, United States
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
Delray Beach, Florida, United States
...and 33 more locations